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 Bextra Information - November 20, 2008
| Food and Drug Administration (FDA) Commissioner, Dr. Lester Crawford, has resigned, after repeated claims that he allowed his agency to "play politics" with drug approvals, and oversaw some very high profile drug safety recalls. The White House quickly named Andrew von Eschenbach, the director of the National Cancer Institute, as acting FDA commissioner | | A report released Thursday found that prescription painkillers prices have gone up as much as 15% since Merck & Co. announced it would no longer sell its popular arthritis drug, Vioxx; was prohibited after heart problems were associated with its prolonged use. Since the September withdrawal, the price for prescription-strength Motrin rose from $30 to $34; while prescriptions for Mobic doubled from 314,000 to 742,000 | | Pfizer Inc. suspended sales and marketing of its arthritis drug Bextra at the request of U.S. and European drug regulators, who said the risks outweigh the drug's benefits. U.S. regulators also asked that Pfizer include a black box warning -- the strongest possible -- on the package insert for its painkiller Celebrex. "For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options," Pfizer said in a statement Thursday. Pfizer said it planned further discussions with the U.S. Food and Drug Administration about the possibility of returning Bextra to the market. In December, the FDA asked doctors to limit prescribing Celebrex and Bextra following indications the drugs may increase the risk of heart attack and stroke. Celebrex, Bextra, and Merck & Co.'s Vioxx, are part of a class of painkillers called COX-2 inhibitors, which are designed to avoid the gastric bleeding associated with older drugs like aspirin. Merck withdrew Vioxx last September after a study showed it doubled the risk of heart attack and stroke compared with a placebo in patients who took it for at least 18 months. The FDA also said in a news release that it would "carefully review" any proposal by Merck & Co. to resume sales of its arthritis drug Vioxx. Bextra had sales in 2004 of $1.3 billion, while sales of Celebrex were $3.3 billion. New prescriptions for Celebrex had plunged in December after the company released data showing the drug may increase the risk of heart attacks and strokes. An advisory panel to the FDA in February concluded that all three medicines posed some level of heart risk, but added Vioxx was safe enough to return to the U.S. market. Most members felt all three drugs should have black box warnings | |
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